Sarepta Therapeutics Provides Update On Ongoing Regulatory Interactions With FDA Regarding AMONDYS 45 And VYONDYS 53 For Treatment Of Duchenne Muscular Dystrophy

Sarepta Therapeutics (NASDAQ: SRPT) plans to submit supplemental new drug applications (sNDA) to the FDA by the end of April 2026, seeking to convert the accelerated approvals of its Duchenne muscular dystrophy treatments, AMONDYS 45 and VYONDYS 53, to traditional approvals. This decision follows positive feedback from the FDA and is supported by data from the ESSENCE confirmatory study and real-world evidence demonstrating the therapies' safety profiles. The adequacy of the submitted data will be evaluated during the review process.